MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE

Catalog Number 153624HM

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the black temperature cord was frequently broken.

Event Description

It was reported that the black temperature cord was frequently broken.

Manufacturer Narrative

The reported event is confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.Visual evaluation of the returned photo sample noted one opened (without original packaging), used temp sensing extension cord.Visual inspection of the photo sample noted that one end of the cable cord connector was broken/cut off.A potential root cause for this failure mode could be ¿"user unfamiliar with device or procedure; user technique".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "for use with compatible 400-series temperature monitors" "do not autoclave or sterilize the monitor cable by ethylene oxide." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE
• Type of Device: DUAL CONNECTOR TO TWO PIN PLUG, MONITOR CABLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18110428
• MDR Text Key: 328057872
• Report Number: 1018233-2023-08039
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 153624HM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other